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Search / Trial NCT06898853

The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes

Launched by THE UNIVERSITY OF NEW SOUTH WALES · Mar 20, 2025

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The immune system plays a pivotal role in dry eye disease (DED) pathogenesis. An increased level of several tear cytokines, chemokines, expression of HLA-DR molecules and activation of antigen presenting cells - dendritic cells (DCs), and lymphocytes all plays a central role in DED pathogenesis . The increased expressions of CD4+ and CD8+ T cells in the ocular surface of DED patients suggest a potential role of adaptive immunity in DED chronicity. The presence of antigen-presenting cells in the ocular surface and the upregulation of MHC II, IL-2, IL-17, IL-6 and IFN- γ and other co-stimulat...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. 18 years of age and above
  • 2. Participants should meet any two of the following DED diagnostic criteria: i) ocular surface disease index score of ≥23 and ii) Oxford staining score of ≥1 iii) Tear meniscus height \< 0.2 mm.
  • Exclusion Criteria:
  • 1. Participants currently using or with previous use of steroids, ciclosporin, lifitegrast or any anti-inflammatory eye drops in the last 6 months.
  • 2. Participants with systemic CsA or tacrolimus
  • 3. Known hypersensitivity or contraindication to the study medication or any of its ingredients.
  • 4. Active intraocular inflammation.
  • 5. Contact lens wear or the use of contact lenses in the last 4 weeks.
  • 6. Active eye infections or history of critical illness.
  • 7. DED secondary to Steven-Johnson syndrome and cicatricial conjunctival disease.
  • 8. Participants with other ocular co-morbidities and medications for glaucoma.
  • 9. Participants with previous history of ocular surgery in the past 6 months.
  • 10. Any other active or inactive systemic condition, structural abnormality such as eyelid malposition's that in the judgment of the investigator could confound study assessments or limit compliance.
  • 11. Pregnant/breastfeeding women

Trial Officials

Fiona Stapleton Professor, PhD

Principal Investigator

The University of New South Wales

About The University Of New South Wales

The University of New South Wales (UNSW) is a leading research institution located in Sydney, Australia, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. As a prominent clinical trial sponsor, UNSW collaborates with healthcare professionals and industry partners to conduct rigorous research aimed at improving patient outcomes and advancing medical practices. The university emphasizes ethical standards, scientific integrity, and community engagement in its clinical research initiatives, contributing to the global body of knowledge in medicine and public health. Through its state-of-the-art facilities and interdisciplinary expertise, UNSW plays a pivotal role in translating research findings into practical applications for the benefit of society.

Locations

Sudney, New South Wales, Australia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported